In the healthcare sector, regulation and innovation are not opposing forces, they are complementary. When well-structured, regulation becomes the foundation that allows new technologies to reach the market with safety, predictability, and credibility.
The challenge lies in balancing patient protection and innovation incentives, ensuring that rigorous processes do not become barriers but rather bridges for technological development.
Regulation as an Instrument of Trust
Regulation is what provides safety, transparency, and predictability to the entire healthcare ecosystem. It establishes minimum quality standards, defines responsibilities, and ensures that products, equipment, and medical software are evaluated technically and ethically before reaching patients.
In Brazil’s case, Anvisa has made significant progress in this balance. In recent years, the agency has been modernizing its processes, adopting international regulatory convergence practices aligned with the International Medical Device Regulators Forum (IMDRF) recommendations.
These initiatives bring the country closer to mature markets such as the European Union and United States, and facilitate mutual recognition of good practices, reducing costs and time for international manufacturers.
Regulation That Stimulates Innovation
A predictable regulatory environment aligned with global standards attracts investment and local development. Manufacturers tend to prioritize countries with clear rules and digital processes, as this reduces uncertainties and facilitates strategic planning.
Innovation depends not only on technology but also on the regulatory environment in which it is applied. When regulation is modern and responsive, it allows the entry of connected devices, artificial intelligence solutions, and software as medical devices (SaMD) in a safe and scalable manner.
Brazil has taken important steps in this direction, such as the digitalization of petition and certification processes, encouragement of emerging technology evaluation, and openness to technical dialogue with the productive sector.
The Importance of Medical Device Consulting
In this scenario, companies working with innovation need partners who understand regulatory complexity and can translate technical requirements into market strategies.
This is where Brisa positions itself: as a medical device consulting firm that not only executes regulatory processes but also acts strategically to transform regulation into competitive advantage.
Brisa’s accumulated experience with manufacturers, distributors, and regulatory agencies allows for the design of customized solutions, aligned with each technology’s moment and the compliance requirements of the Brazilian market.
Innovating with Safety Means Innovating with Regulation
The future of healthcare lies in the convergence between technology and regulation.
Companies that understand this balance can innovate faster, build credibility, and achieve sustainable results.
At Brisa, we believe that innovating with safety means innovating with regulation. Therefore, our commitment is to strengthen this link, so that technological advancement reaches those who truly matter faster: healthcare professionals and patients.
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